To Validate Point Mini User Needs

The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.

Study Overview

• Status: Withdrawn
• Conditions: Amputation; Traumatic, Hand; Amputation, Congenital
• Intervention / Treatment: Device: Point Mini

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver | Anschutz Medical Campus
    • Lafayette, Colorado, United States, 80026
      • Point Designs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Partial hand loss with at least index and/or middle fingers loss at the MCP level
• Intact thumb with full range of motion
• Fluent in English
• Between the ages of 5 and 15 years

Exclusion Criteria:

• Patients with a residual limb that is unhealed from the amputation surgery
• Unhealed wounds
• Significant cognitive deficits as determined upon clinical evaluation
• Significant neurological deficits as determined upon clinical evaluation
• Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
• Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
• Serious uncontrolled medical problems as judged by the project therapist

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prosthesis; Patient is temporarily fit with Point Mini finger prosthetic system	Device: Point Mini; The Point Mini finger prosthetic system consists of 1-4 ratcheting mechanical digits and mounting brackets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAL-1	User wears Point Mini(s) for a entire session without discomfort (Pass/Fail)	Day 1 (8 hours)
VAL-2	User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail)	Day 1 (10 minutes)
VAL-3.1	User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail)	Day 1 (10 minutes)
VAL-3.2	User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail)	Day 1 (10 minutes)
VAL-4	User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail)	Day 1 (10 minutes)
VAL-5	User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail)	Day 1 (10 minutes)
VAL-6	User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail)	Day 1 (10 minutes)
VAL-7	User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail)	Day 1 (10 minutes)
VAL-8	User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail)	Day 1 (10 minutes)
VAL-9	User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail)	Day 1 (8 hours)

Collaborators and Investigators

• Sponsor: Point Designs
• Collaborators: University of Colorado, Denver; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Levin Sliker, PhD, CEO, Point Designs

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2025
• Primary Completion (Actual): July 29, 2025
• Study Completion (Actual): July 29, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Amputation, Congenital
• Other Study ID Numbers: 445969; 4R44HD113485-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes